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  6. Cleared 510(k) Submissions with Supporting Documents - 2023
  1. Substantially Equivalent 510(k) Device Information

Cleared 510(k) Submissions with Supporting Documents - 2023

This list includes cleared 510(k) submissions for 2023 for which we have supporting documents available, and reflects the information as of the clearance date. It is not updated with regard to applicant or application status change.

The clearances are listed by clearance date in reverse chronological order.

510(k) Number Applicant Device Name Decision Date
BK230806 Immucor, Inc.
Norcross, GA		 ImmuLINK (v3.0) 4/25/2023
BK230824 Fresenius Kabi AG
Lake Zurich, IL		 AMICUS Separator System 4/21/2023
BK230804 Roche Diagnostics
Indianapolis, IN		 Elecsys HIV Duo 4/4/2023
BK220790 Blood Bank Computer Systems, Inc
Bonney Lake, WA		 Blood Bank Control System, Version 6.0 2/17/2023
BK220775 Hydra Srl
Italy		 Procedure Tray - Lipoaspirate fat harvest and injection kit 1/4/2023

 

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